Calcium Saccharate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₆H₈CaO₈.4H₂O 320.26

D-Glucaric acid, calcium salt (1:1) tetrahydrate;

Calcium D-glucarate (1:1), tetrahydrate CAS RN: 5793-89-5.

1 DEFINITION

Calcium Saccharate is the calcium salt of D-saccharic acid. It contains NLT 98.5% and NMT 102.0% of C₆H₈CaO₈.4H₂O.

2 IDENTIFICATION

A. IDENTIFICATION TESTS-GENERAL, Calcium (191)

Sample: 0.2 g

Analysis: Dissolve the Sample in 10 mL of water by the addition of 2 mL of hydrochloric acid.

Acceptance criteria: Meets the requirements

B. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197M: Meets the requirements

3 ASSAY

Change to read:

PROCEDURE

Sample: 600 mg

Blank: 150.0 mL of water

Titrimetric system (See Titrimetry (541).)

Mode: Direct titration

Titrant: 0.05 M edetate disodium VS

Endpoint detection: Visual

Analysis: Dissolve the Sample in 150 mL of water with the aid of a sufficient volume of hydrochloric acid. While stirring, preferably with a magnetic stirrer, add 30 mL of Titrant from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue. Continue the titration to a blue endpoint. Perform a Blank determination and make any necessary corrections.

Calculate the percentage of calcium saccharate (C₆H₈CaO₈.4H₂O) in the portion of Calcium Saccharate taken:

Result = {[(V_S-V_B) x M _{(ERR 1-Jan-2022)} × F]/W} x 100

V_S = Titrant volume consumed by the Sample (mL)

V_B = Titrant volume consumed by the Blank (mL)

M = actual molarity of the Titrant (mmol/mL) (ERR 1-Jan-2022)

F = equivalency factor, 320.26 mg/mmol (ERR 1-Jan-2022)

W = Sample weight (mg)

Acceptance criteria: 98.5%-102.0%

4 IMPURITIES

4.1 CHLORIDE AND SULFATE, Chloride (221)

Standard: 0.50 mL of 0.020 N hydrochloric acid

Sample: 0.50 g dissolved in 10 mL of water by the addition of 2 mL of nitric acid

Acceptance criteria: NMT 0.07%

4.2 CHLORIDE AND SULFATE, Sulfate (221)

Standard: 0.6 mL of 0.020 N sulfuric acid

Sample: 0.50 g dissolved in 10 mL of water by the addition of 2 mL of hydrochloric acid

Acceptance criteria: NMT 0.12%

Sucrose and Reducing Sugars

Sample: 0.5 g

Analysis: Dissolve the Sample in 10 mL of water with the addition of 2 mL of hydrochloric acid, and boil the solution for about 2 min. Cool, add 15 mL of sodium carbonate TS, allow to stand for 5 min, and filter. Add 5 mL of the clear filtrate to about 2 mL of alkaline cupric tartrate TS, and boil for 1 min.

Acceptance criteria: No red precipitate is formed immediately.

5 SPECIFIC TESTS

Optical Rotation, Specific Rotation〈781S〉

Sample solution: 60 mg/mL in 4.8 N hydrochloric acid that has been allowed to stand for 1 h

Acceptance criteria: +18.5° to +22.5°

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Calcium Saccharate RS